Trial Outcomes & Findings for LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs (NCT NCT03887650)
NCT ID: NCT03887650
Last Updated: 2023-09-15
Results Overview
Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
90 participants
Primary outcome timeframe
Up to 120 postoperative hours
Results posted on
2023-09-15
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine 1.3%
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
|
Bupivacaine 0.5% With Adjuncts
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
|
|---|---|---|
|
Preoperative-48 Hours Postoperative
STARTED
|
45
|
45
|
|
Preoperative-48 Hours Postoperative
COMPLETED
|
45
|
44
|
|
Preoperative-48 Hours Postoperative
NOT COMPLETED
|
0
|
1
|
|
48-96 Hours Postoperative
STARTED
|
45
|
44
|
|
48-96 Hours Postoperative
COMPLETED
|
45
|
42
|
|
48-96 Hours Postoperative
NOT COMPLETED
|
0
|
2
|
|
60 Postoperative Days
STARTED
|
45
|
42
|
|
60 Postoperative Days
COMPLETED
|
44
|
42
|
|
60 Postoperative Days
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Liposomal Bupivacaine 1.3%
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
|
Bupivacaine 0.5% With Adjuncts
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
|
|---|---|---|
|
Preoperative-48 Hours Postoperative
Withdrawal by Subject
|
0
|
1
|
|
48-96 Hours Postoperative
Withdrawal by Subject
|
0
|
2
|
|
60 Postoperative Days
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine 1.3%
n=45 Participants
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
|
Bupivacaine 0.5% With Adjuncts
n=45 Participants
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
n=5 Participants
|
73 years
n=7 Participants
|
73 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
31.30 kg/m^2
n=5 Participants
|
31.60 kg/m^2
n=7 Participants
|
31.35 kg/m^2
n=5 Participants
|
|
ASA Physical Status Classification
|
2 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
2 units on a scale
n=5 Participants
|
|
Preoperative shoulder pain
None
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Preoperative shoulder pain
Mild
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Preoperative shoulder pain
Moderate
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Preoperative shoulder pain
Severe
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Comorbidities
Diabetes Miletus : yes
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Comorbidities
Diabetes Miletus : no
|
39 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Comorbidities
Hyperlipidemia : yes
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Comorbidities
Hyperlipidemia : no
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Comorbidities
Hypertension : yes
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Comorbidities
Hypertension : no
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Comorbidities
COPD : yes
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Comorbidities
COPD : no
|
45 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Comorbidities
RA : yes
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Comorbidities
RA : no
|
45 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Comorbidities
Opioids at home : yes
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Comorbidities
Opioids at home : no
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 120 postoperative hoursPopulation: 3 patients withdrew from Bupivacaine 0.5% with Adjuncts group.
Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs)
Outcome measures
| Measure |
Liposomal Bupivacaine 1.3%
n=45 Participants
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
|
Bupivacaine 0.5% With Adjuncts
n=42 Participants
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
|
|---|---|---|
|
Total Opioid Consumption
|
71.25 MME
Interval 43.0 to 120.0
|
90.30 MME
Interval 57.37 to 133.43
|
SECONDARY outcome
Timeframe: from the time of the block injection until discharge, assessed up to 72 postoperative hours.Population: Missing data for 2 patients from the Liposomal Bupivacaine 1.3% group. 3 patients withdrew consents from the Bupivacaine 0.5% with Adjuncts group.
From block time to the first dose of opioids given, measured in hours.
Outcome measures
| Measure |
Liposomal Bupivacaine 1.3%
n=43 Participants
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
|
Bupivacaine 0.5% With Adjuncts
n=42 Participants
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
|
|---|---|---|
|
Time to First Opioid Medication
|
10.5667 hours
Interval 5.8 to 20.85
|
12.025 hours
Interval 4.404 to 21.983
|
SECONDARY outcome
Timeframe: 24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60Population: Three patients withdrew consent from the control group (Bupivacaine 0.5% with adjuncts) and one from the liposomal bupivacaine group. The rest is missing data from lost to follow-up.
Pain assessment is categorized as minimum, maximum, and average pain scores reported by patients using questions from the Modified Brief Pain Inventory-short form (MBPI-SF) during the following intervals; PACU-24, 24-48, 48-72, and 72-96 postoperative hours, and at day 60. This form collected minimum, maximum, and average on a numeric pain scale (0-10) where 0 is no pain and 10 is the worst pain.
Outcome measures
| Measure |
Liposomal Bupivacaine 1.3%
n=45 Participants
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
|
Bupivacaine 0.5% With Adjuncts
n=45 Participants
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
|
|---|---|---|
|
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
PACU-24 hours Maximum
|
2.00 units on a scale 0-10
Interval 0.0 to 4.5
|
1.00 units on a scale 0-10
Interval 0.0 to 4.5
|
|
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
PACU-24 hours Average
|
1.00 units on a scale 0-10
Interval 0.0 to 2.0
|
0.00 units on a scale 0-10
Interval 0.0 to 3.5
|
|
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
24-48 hours Minimum
|
0.00 units on a scale 0-10
Interval 0.0 to 2.0
|
2.00 units on a scale 0-10
Interval 0.0 to 3.75
|
|
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
24-48 hours Maximum
|
4.50 units on a scale 0-10
Interval 1.0 to 6.0
|
7.00 units on a scale 0-10
Interval 5.0 to 8.0
|
|
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
PACU
|
0.00 units on a scale 0-10
Interval 0.0 to 1.0
|
0.00 units on a scale 0-10
Interval 0.0 to 1.5
|
|
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
PACU-24 hours Minimum
|
0.00 units on a scale 0-10
Interval 0.0 to 1.0
|
0.00 units on a scale 0-10
Interval 0.0 to 0.0
|
|
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
24-48 hours Average
|
2.00 units on a scale 0-10
Interval 0.0 to 3.75
|
4.00 units on a scale 0-10
Interval 3.0 to 5.0
|
|
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
48-72 hours Minimum
|
1.00 units on a scale 0-10
Interval 0.0 to 2.0
|
2.00 units on a scale 0-10
Interval 1.0 to 3.0
|
|
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
48-72 hours Maximum
|
4.00 units on a scale 0-10
Interval 1.75 to 6.0
|
6.00 units on a scale 0-10
Interval 4.5 to 7.0
|
|
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
48-72 hours Average
|
2.00 units on a scale 0-10
Interval 1.0 to 3.25
|
3.00 units on a scale 0-10
Interval 2.0 to 5.0
|
|
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
72-96 hours Minimum
|
0.50 units on a scale 0-10
Interval 0.0 to 2.0
|
2.00 units on a scale 0-10
Interval 0.0 to 2.0
|
|
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
72-96 hours Maximum
|
4.00 units on a scale 0-10
Interval 1.75 to 5.25
|
5.00 units on a scale 0-10
Interval 4.0 to 7.0
|
|
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
72-96 hours Average
|
2.00 units on a scale 0-10
Interval 1.0 to 3.0
|
3.00 units on a scale 0-10
Interval 2.0 to 4.0
|
|
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
60 days postoperative Maximum
|
5.00 units on a scale 0-10
Interval 2.0 to 6.0
|
6.00 units on a scale 0-10
Interval 4.25 to 8.0
|
|
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
60 days postoperative Average
|
1.00 units on a scale 0-10
Interval 0.25 to 3.0
|
2.00 units on a scale 0-10
Interval 1.0 to 3.0
|
|
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
60 days postoperative Minimum
|
0.00 units on a scale 0-10
Interval 0.0 to 0.75
|
0.00 units on a scale 0-10
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: From the date of admission until discharge, assessed up to 72 hours.From the date and time of admission to the date and time of discharge, Measured in hours.
Outcome measures
| Measure |
Liposomal Bupivacaine 1.3%
n=45 Participants
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
|
Bupivacaine 0.5% With Adjuncts
n=45 Participants
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
|
|---|---|---|
|
Hospital Length-of-stay
|
31.05 hour
Interval 29.67 to 32.53
|
31.63 hour
Interval 30.63 to 36.58
|
SECONDARY outcome
Timeframe: POD4 - 60 daysPopulation: One patient withdrew consent from the Liposomal group just prior to 60 postoperative days, and three patients withdrew consent from the control group at the end of days 2, 3, and 4. The other missing data is from patients who lost to follow up from both groups.
Patient overall satisfaction with pain control was assessed two times; on the fourth and the 60th postoperative days. It was assessed using a numeric scale (0-10) where 0 is very dissatisfied while 10 is extremely satisfied. The results indicated only the percentage of participants who reported a 10/10 satisfaction rate.
Outcome measures
| Measure |
Liposomal Bupivacaine 1.3%
n=45 Participants
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
|
Bupivacaine 0.5% With Adjuncts
n=42 Participants
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
|
|---|---|---|
|
Assessment of Patient Overall Satisfaction With Pain Control
POD4 · 10/10
|
32 Participants
|
24 Participants
|
|
Assessment of Patient Overall Satisfaction With Pain Control
POD4 · below 10
|
9 Participants
|
17 Participants
|
|
Assessment of Patient Overall Satisfaction With Pain Control
POD4 · Missing data
|
4 Participants
|
1 Participants
|
|
Assessment of Patient Overall Satisfaction With Pain Control
POD60 · 10/10
|
27 Participants
|
28 Participants
|
|
Assessment of Patient Overall Satisfaction With Pain Control
POD60 · below 10
|
12 Participants
|
13 Participants
|
|
Assessment of Patient Overall Satisfaction With Pain Control
POD60 · Missing data
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At PACU and Postoperative day 2Population: Although one patient from the control group decided to withdraw consent at the end of the second day following surgery, their data was included for this outcome as the withdrawal happened after collection. However, there was some missing data.
On a distress scale of (0 -10) with 0 = not at all and 10 = very much distressed, the scores were gathered and the results are grouped to show the percentage of either the presence of distress (any positive score) or no distress, assessed at two times; at the PACU and the second postoperative day.
Outcome measures
| Measure |
Liposomal Bupivacaine 1.3%
n=45 Participants
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
|
Bupivacaine 0.5% With Adjuncts
n=45 Participants
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
|
|---|---|---|
|
Incidence of Distress From Block Numbness
PACU distress · No distress
|
31 Participants
|
31 Participants
|
|
Incidence of Distress From Block Numbness
PACU distress · any distress
|
14 Participants
|
14 Participants
|
|
Incidence of Distress From Block Numbness
PACU distress · Missing data
|
0 Participants
|
0 Participants
|
|
Incidence of Distress From Block Numbness
POD2 Distress · No distress
|
32 Participants
|
31 Participants
|
|
Incidence of Distress From Block Numbness
POD2 Distress · any distress
|
12 Participants
|
12 Participants
|
|
Incidence of Distress From Block Numbness
POD2 Distress · Missing data
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1, after Day 1 (day 2 to 60), and at postoperative day 60Using the sensory assessment test, the results show the percentage of participants who had the return of first sensation and full sensation either on Day 1, after Day 1 (day 2 to 60), and at postoperative day 60.
Outcome measures
| Measure |
Liposomal Bupivacaine 1.3%
n=45 Participants
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
|
Bupivacaine 0.5% With Adjuncts
n=45 Participants
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
|
|---|---|---|
|
Duration of Sensory Nerve Block
First sensation · Missing data
|
1 Participants
|
2 Participants
|
|
Duration of Sensory Nerve Block
Full sensation · Returned on day 1 after the block
|
11 Participants
|
11 Participants
|
|
Duration of Sensory Nerve Block
Full sensation · Returned on day 2-60
|
27 Participants
|
27 Participants
|
|
Duration of Sensory Nerve Block
Full sensation · Not by day 60
|
0 Participants
|
2 Participants
|
|
Duration of Sensory Nerve Block
Full sensation · Missing data
|
7 Participants
|
5 Participants
|
|
Duration of Sensory Nerve Block
First sensation · Returned on day 1 after the block
|
35 Participants
|
33 Participants
|
|
Duration of Sensory Nerve Block
First sensation · Returned on day 2-60
|
9 Participants
|
10 Participants
|
|
Duration of Sensory Nerve Block
First sensation · Not by day 60
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0-96 postoperative hoursPopulation: Three patients were missing from (Bupivacaine 0.5% with Adjuncts) group because of withdrawal.
The postoperative day that patients in each group took their last opioid, from the end of surgery up to 96 postoperative hours.
Outcome measures
| Measure |
Liposomal Bupivacaine 1.3%
n=45 Participants
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
|
Bupivacaine 0.5% With Adjuncts
n=42 Participants
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
|
|---|---|---|
|
Day of the Final Opioids Used
|
4 day
Interval 1.5 to 4.0
|
4 day
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.The Motor function was assessed by shoulder abduction and elbow flexion using the Oxford scale of muscle strength grading (Muscle Grading Scores 0-5): 0= No detectable muscle contraction (visible or palpation) 1. Detectable contraction (visible or palpation), but no movement achieved 2. Limb movement achieved, but unable to move against gravity 3. Limb movement against the resistance of gravity 4. Limb movement against gravity and external resistance 5. Normal strength The results were grouped to show the return of any movement at the PACU, Day 1, after Day 1 (day2-60), and on day 60. And the return of full movement between day 2 and 60 and at day 60, in addition to the missing data.
Outcome measures
| Measure |
Liposomal Bupivacaine 1.3%
n=45 Participants
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
|
Bupivacaine 0.5% With Adjuncts
n=45 Participants
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
|
|---|---|---|
|
Motor Recovery
Any movement in PACU
|
1 Participants
|
11 Participants
|
|
Motor Recovery
Any movement in day1
|
4 Participants
|
3 Participants
|
|
Motor Recovery
Any movement after day1
|
38 Participants
|
29 Participants
|
|
Motor Recovery
Any movement missing data
|
2 Participants
|
2 Participants
|
|
Motor Recovery
Return of full movement day 2-60
|
32 Participants
|
31 Participants
|
|
Motor Recovery
Not yet by day 60
|
3 Participants
|
6 Participants
|
|
Motor Recovery
Return of full movement missing data
|
10 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-24, 24-48, 48-72, and 72-120 postoperative hours.Population: One patient withdrew consent on the second postoperative day from the control group, then two patients withdrew on the third and fourth postoperative days from the control group.
Opioid use was calculated using the Morphine MilliEquevalent per day, this was assessed daily during the postoperative period, 0-24, 24-48, 48-72, and 72-120 postoperative hours.
Outcome measures
| Measure |
Liposomal Bupivacaine 1.3%
n=45 Participants
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
|
Bupivacaine 0.5% With Adjuncts
n=45 Participants
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
|
|---|---|---|
|
Total Amount of Opioid Consumed During the Indicated Time Periods
0-24 hours
|
25.00 MME/day
Interval 25.0 to 39.37
|
25.00 MME/day
Interval 25.0 to 37.5
|
|
Total Amount of Opioid Consumed During the Indicated Time Periods
24-48 hours
|
16.00 MME/day
Interval 0.0 to 38.75
|
23.25 MME/day
Interval 9.75 to 39.37
|
|
Total Amount of Opioid Consumed During the Indicated Time Periods
48-72 hours
|
2.00 MME/day
Interval 0.0 to 8.0
|
5.00 MME/day
Interval 0.0 to 15.0
|
|
Total Amount of Opioid Consumed During the Indicated Time Periods
72-120 hours
|
10.00 MME/day
Interval 0.0 to 27.0
|
15.00 MME/day
Interval 0.0 to 37.5
|
Adverse Events
Liposomal Bupivacaine 1.3%
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Bupivacaine 0.5% With Adjuncts
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Liposomal Bupivacaine 1.3%
n=45 participants at risk
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
|
Bupivacaine 0.5% With Adjuncts
n=45 participants at risk
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
1/45 • Number of events 1 • Adverse events were collected up to 60 postoperative days.
|
2.2%
1/45 • Number of events 1 • Adverse events were collected up to 60 postoperative days.
|
|
Surgical and medical procedures
Swelling
|
2.2%
1/45 • Number of events 1 • Adverse events were collected up to 60 postoperative days.
|
0.00%
0/45 • Adverse events were collected up to 60 postoperative days.
|
|
Surgical and medical procedures
Inflammation
|
2.2%
1/45 • Number of events 1 • Adverse events were collected up to 60 postoperative days.
|
0.00%
0/45 • Adverse events were collected up to 60 postoperative days.
|
|
Surgical and medical procedures
Bruising
|
11.1%
5/45 • Number of events 5 • Adverse events were collected up to 60 postoperative days.
|
6.7%
3/45 • Number of events 3 • Adverse events were collected up to 60 postoperative days.
|
|
Ear and labyrinth disorders
Ringing in ears
|
2.2%
1/45 • Number of events 1 • Adverse events were collected up to 60 postoperative days.
|
2.2%
1/45 • Number of events 1 • Adverse events were collected up to 60 postoperative days.
|
|
Nervous system disorders
Numbness and tingling
|
2.2%
1/45 • Number of events 1 • Adverse events were collected up to 60 postoperative days.
|
0.00%
0/45 • Adverse events were collected up to 60 postoperative days.
|
|
General disorders
Nausea and vomiting
|
17.8%
8/45 • Number of events 8 • Adverse events were collected up to 60 postoperative days.
|
35.6%
16/45 • Number of events 16 • Adverse events were collected up to 60 postoperative days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place